Catalog Number

WKMC118

Brand Name

Halyard

Version/Model Number

WKMC118_0003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OKV

Product Code Name

Obstetrical kit

Public Device Record Key

a2bd43f9-027f-42a0-ace4-de972e3f1d0b

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 21, 2021

Package DI Number

20809160351045

Quantity per Package

3

Contains DI Package

10809160351048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-